Abstract

Background

Evidence suggests that poor recruitment into clinical trials rests on a patient ‘deficit’
model – an inability to comprehend trial processes. Poor communication has also been
cited as a possible barrier to recruitment. A qualitative patient interview study
was included within the feasibility stage of a phase III non-inferiority Randomized
Controlled Trial (RCT) (SPARE, CRUK/07/011) in muscle invasive bladder cancer. The
aim was to illuminate problems in the context of randomization.

Methods

The qualitative study used a ‘Framework Analysis’ that included ‘constant comparison’
in which semi-structured interviews are transcribed, analyzed, compared and contrasted
both between and within transcripts. Three researchers coded and interpreted data.

Results

The main theme applying to the majority of the sample was confusion and ambiguity.
There was little indication that confusion directly impacted on decisions to enter
the SPARE trial. However, confusion did appear to impact on ethical considerations
surrounding ‘informed consent’, as well as cause a sense of alienation between patients
and health personnel.

Sub-optimal communication in many guises accounted for the confusion, together with
the logistical elements of a trial that involved treatment options delivered in a
number of geographical locations.

Conclusions

These data highlight the difficulty of providing balanced and clear trial information
within the UK health system, despite best intentions. Involvement of multiple professionals
can impact on communication processes with patients who are considering participation
in RCTs. Our results led us to question the ‘deficit’ model of patient behavior. It
is suggested that health professionals might consider facilitating a context in which
patients feel fully included in the trial enterprise and potentially consider alternatives
to randomization where complex interventions are being tested.